Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer

Not Applicable

Completed

• Conditions: Urinary Bladder Cancer
• Interventions: Other: The CanMoRe programme; Other: Home exercise

• Registration Number: NCT03998579
• Lead Sponsor: Karolinska Institutet

Brief Summary

The main objective of the CanMoRe study is to evaluate the impact of a standardized and individually adapted exercise intervention in Primary Health Care aiming at improving physical function (primary outcome) and habitual physical activity, health related quality of life, fatigue and psychological well-being in patients undergoing radical cystectomy due to urinary bladder cancer.

Detailed Description

The most common treatment for solid cancer tumours is surgery, often in combination with chemo- and/or radiotherapy. To minimise the postoperative complications is important in today's health care. Early mobilisation at the ward and physical activity at home after discharge, have been shown to be important parts to reduce complications. Common complications after abdominal surgery are postoperative pulmonary complications and venous thrombosis. One of the conditions that suffers the most from different kinds of postoperative complications is radical cystectomy due to urinary bladder cancer. Complications after radical cystectomy could be direct related to the patients' high age and also high degree of comorbidity.

There is today strong evidence that physical activity has a positive impact on health, survival and quality of life. Patients who have been treated for urinary bladder cancer are not sufficiently physical active and suffer from readmissions to hospital due to complications. Therefore, there is a need for developing and testing a physical rehabilitation programme to support patients who have a radical cystectomy, in the early postoperative period.

The CanMoRe study is a randomized controlled trial with a single-blinded design evaluating an exercise intervention in Primary Health Care as part of the CanMoRe programme. In addition, a qualitative study (interviews) on patient's experience of the programme will be conducted as well as data gathered on factors that might influence the implementation of the programme.

Then CanMoRe programme consists of preoperative information, the Activity Board used for enhanced mobilization during hospital stay, a 12-week, (1 h, 2 times/week) standardized and individually adapted exercise intervention in Primary Health Care and behavioral support for daily physical activity. The CanMoRe programme is evaluated in two steps, i.e. the in-hospital intervention using the Activity Board (published) and the exercise intervention in Primary Health Care reported herein.

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-26
• Study Start: 2019-09-01
• Primary Completion: 2022-11-15
• Study Completion: 2023-06-20
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients who are planned for a robotic assisted laparoscopic radical cystectomy due to urinary bladder cancer at the Karolinska University Hospital Solna will be included in the trial. The patients should be able to talk and understand Swedish, live in the Stockholm County Council area and be mobile with or without walking aid.

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Exclusion Criteria

• Patients who will undergo radical cystectomy on a non-curative basis will not be included.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized exercise	The CanMoRe programme	The intervention group get a referral to physiotherapist in Primary Health Care in Stockholm County Council, close to where they live. Within the third week after discharge, the patients begin twelve weeks of biweekly exercise. The physical exercise is individually targeted aerobic and strength exercises, based on international recommendations for persons with cancer disease. The program is approved by resposible surgeons.
Active control group	Home exercise	Oral and written information of a home-based exercise programme and information of supportive techniques to improve physical activity

Primary Outcome Measures

Name	Time	Method
Six-minute walk test	Change from baseline to after 12 weeks intervention	The test reproduces activity of daily living at a sub maximal level. Output: meters Score: 0-900.

Secondary Outcome Measures

Name	Time	Method
ActivPAL accelerometer	Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge	Habitual physical activity, measured for 7 consecutive days. Output: number of steps per day.
Chair stand test	Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge	Measure of leg strength. Output: Scale 0-30
Hand grip strength	Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge,	Measure of hand grip strength (Jamar hand dynamometer). Output: Kilo 0-60
Piper Fatigue Scale	Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge	Fatigue. Output: Scale 0-10. A higher score is worse, i.e more fatigue
European Organisation for Research and Treatment of Cancer (EORTC) Quality of life for cancer patients QLQ-C30	Measurement 1: Baseline Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge	Health related quality of life. Output: Scale 0-100. A higher score is worse outcome. For more information see https://qol.eortc.org/questionnaires/
EORTC QLQ-BLM30	Measurement 1: Baseline Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge	Health related quality of life specific for bladder cancer Output: Scale 0-100, a higher score is worse
Hospital Anxiety and Depression Scale (HADS)	Measurement 1: Baseline, Measurement 2: 12 weeks. Measurement 3: 1 year after discharge	Psychological wellbeing. Output: Scale 0-21. A higher score is worse
Complications	Collected from journals using standardized time frames at 30 and 90 days	Complications such as Pneumonia Output: according to Clavien - Dindo classification
Six-minute walk test	Measurement 3: 1 year after discharge	The test reproduces activity of daily living at a sub maximal level. Output: meters Score: 0-900.
Readmission	Collected from journals using standardized time frames at 30 and 90 days	Readmissions to hospital. Output: Yes/No
Numeric rating scale (NRS)	Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge	Pain. Output: Scale 0-10, A higher score is worse i.e more pain

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden